Overview
EN ISO 14375:2023 (identical to ISO 14375:2018) defines performance requirements and test methods for child-resistant non-reclosable packaging for pharmaceutical products. Adopted by CEN in March 2023, the standard is intended for type approval of a specific package design (formed from specified materials) and is explicitly not intended for routine quality-assurance testing.
Key topics and requirements
- Scope and purpose: Performance requirements and methods of test for non-reclosable packaging designated child‑resistant; used for type approval only.
- Definitions: Clear terms such as child-resistant package, non-reclosable child-resistant package, unit dose, substitute product, and type approval.
- Performance testing: Two main test categories:
- Child test - evaluates whether children (panel testing) can access contents.
- Adult test - verifies that adults can use the package as intended.
- Test structure: Detailed test process covering:
- Principle, samples and sample preparation
- Step‑by‑step procedure for child and adult tests
- Evaluation criteria and overall test result
- Required test reporting
- Supporting material:
- Annex A - guidance for supervisors during child tests
- Annex B - normative test charts
- Annex C - discussion on the suitability of sequential procedures used in testing
Practical applications
- Packaging designers and manufacturers: Use the standard to design and validate non‑reclosable, child‑resistant pharmaceutical packaging for market entry and type approval.
- Pharmaceutical companies: Demonstrate that packaging meets recognized performance tests before launch.
- Testing laboratories and conformity assessment bodies: Conduct panel tests and prepare test reports in line with the standard’s procedures and annexes.
- Regulators and procurement teams: Reference the standard when assessing packaging safety claims or specifying requirements in tenders and regulatory submissions.
- Risk and safety specialists: Use the standard to inform product risk assessments and to ensure packaging is an appropriate safety barrier (recognizing packaging is the last line of defence).
Related standards and bodies
- Prepared by ISO/TC 122 (Packaging) and adopted by CEN/TC 261 (Packaging).
- EN ISO 14375 complements other packaging and child‑safety guidance; users should consult national regulatory requirements in addition to this standard.
Keywords: EN ISO 14375:2023, ISO 14375, child-resistant packaging, non-reclosable packaging, pharmaceutical packaging, performance requirements, type approval, packaging testing, child test, adult test.